Slide 1: Pipeline: Respiratory, Inflammation & Autoimmunity (RIA)
Pipeline: Respiratory, Inflammation & Autoimmunity (RIA) Inhaled therapeutic leadership; spearheading immunology biologics Bing Yao, Head of MedImmune Respiratory, Inflammation & Autoimmunity iMED
Slide 2: Respiratory: Transform patient outcomes in asthma, COPD & IPF
Respiratory: Transform patient outcomes in asthma, COPD & IPF Deliver inhaled 1 2 Expand with innovative 3 Transforming disease therapies precision therapies management Short term Medium term Long term 2 – Pipeline: Respiratory, Inflammation & Autoimmunity (RIA)
Slide 3: Respiratory: Industry-leading portfolio
Respiratory: Industry-leading portfolio Phase I Phase II Phase III / Registration Small molecule Large molecule Small molecule Large molecule Small molecule AZD1419 brodalumab* AZD2115 benralizumab PT003 TLR9 IL17R MABA IL5R LAMA/LABA asthma asthma COPD severe asthma COPD AZD7624 AZD9412 PT008 tralo
Slide 4: COPD: Inhaled portfolio addresses all disease severities and provides device choice
COPD: Inhaled portfolio addresses all disease severities and provides device choice Diagnosed Adapted from GOLD with LABA/ICS LAMA/LABA/ICS guidelines exacerbation Increased risk of exacerbation Diagnosed with LAMA LAMA/LABA symptoms Symptoms worsening “Passive” dry powder ”Active” device, pMDI, inh
Slide 5: Asthma: Inhaled portfolio addresses all GINA steps and provides device choice
Asthma: Inhaled portfolio addresses all GINA steps and provides device choice Adapted from LAMA/ICS LAMA/LABA/ICS GINA guidelines ’As Needed’ LABA/ICS ICS GINA classification 1 2 3 4 5 “Passive” dry powder ”Active” device, pMDI, inhaler, DPI, most preferred for young, elderly commonly used and for s
Slide 6: Severe asthma: Targeting distinct patient subsets
Severe asthma: Targeting distinct patient subsets High Th2 driven | EOS low Th2 driven | EOS dominant B A 20% 35% Serum periostin level Anti-IL-13 Anti-IL-5 Anti-IL-13 Th2 low | EOS low Th2 low | EOS high D C 30% 15% Anti-IL-5 Low Low High Blood eosinophil level 6 – Pipeline: Respiratory, Inflammati
Slide 7: Benralizumab (severe asthma): Only IL5 receptor mAb in Phase III
Benralizumab (severe asthma): Only IL5 receptor mAb in Phase III Phase IIb data Exacerbation rate reduction reduction relative to placebo Annual exacerbation rate • Potent reduction in eosinophils • Reduction in asthma exacerbation • Improvement in lung function Baseline blood eosinophil count cutof
Slide 8: Benralizumab (COPD): First mAb to show eosinophilic inflammation reduction
Benralizumab (COPD): First mAb to show eosinophilic inflammation reduction Mean change from baseline in FEV1 over time Phase IIa data (PP population) • First anti-IL5 / IL5R to demonstrate lung function improvement P = 0.014 • Primary endpoint not achieved, but trend toward reduction of exacerbation
Slide 9: Tralokinumab (severe asthma): Targeting IL13, a central TH2 cytokine
Tralokinumab (severe asthma): Targeting IL13, a central TH2 cytokine AER for tralokinumab 300 mg Q2W vs Phase IIb data placebo over 52 weeks Periostin- low (15) 40% 32% DPP-4 • Identified potential (273, -53) low (8) 20% responder population 7% 0% (886, -88) • Identified promising -20% biomarkers -4
Slide 10: Inflammation & Autoimmunity: Series of first & best-in-class assets
Inflammation & Autoimmunity: Series of first & best-in-class assets Phase I Phase II Phase III / Registration Large molecule Large molecule Small molecule Large molecule Small molecule MEDI5872* mavrilimumab RDEA3170 brodalumab* lesinurad B7RP1 GM-CSFR SURI IL17R SURI SLE rheum arthritis gout psoria
Slide 11: Lesinurad (gout): Progressing to regulatory submission
Lesinurad (gout): Progressing to regulatory submission CLEAR 1 and CLEAR 2: Proportion Lesinurad in gout of patients achieving sUA <6 mg/dL at Month 6 – NRI 60% 54% 55% • Gout affects ~15m patients 50% − Potential to cause bone, joint, kidney damage and 40% associated with CV disease and its co-morb
Slide 12: Targeting IFNα / IFNαR in lupus
Targeting IFNα / IFNαR in lupus Sifalimumab binds directly to Anifrolumab targeting broader spectrum IFNα neutralising IFNα subtypes of interferons (IFNα, IFNβ, and IFNω) IFN-β IFN-ω IFN-α Phase IIb lupus study validates Receptor-targeting potentially better interferon targeting: Primary and efficac
Slide 13: Sifalimumab (lupus): Significant improvement in SLE responder index
Sifalimumab (lupus): Significant improvement in SLE responder index and organ specific measurements Endpoint at day 365 Day 1 SRI (4) SRI (6) SRI (8) All-comers population Placebo (%) 45.4 37.4 24.5 (N=98 - 108) 1200 mg dose (%), 59.8 53.3 41.8 (N=98 - 107) Effect size (%) 14.4 15.9 17.3 P-value* 0.
Slide 14: Mavrilimumab (RA): First-in-class anti-GM-CSFRα antibody
Mavrilimumab (RA): First-in-class anti-GM-CSFRα antibody • Phase IIb data ACR efficacy responses at day 169 80 73.4 • 45–74% of patients on Placebo (N=81) 70 anti-TNF fail to achieve 61.2 Mav. 30mg (N=81) 60 Mav. 100mg (N=85) an ACR50 50.6 Subjects (%) 50 Mav. 150mg (N=79) 40.5 • Mavrilimumab inhibi
Slide 15: Brodalumab (psoriasis, psoriatic arthritis, asthma): Unique receptor-targeting approach
Brodalumab (psoriasis, psoriatic arthritis, asthma): Unique receptor-targeting approach Psoriasis IL-17A/F • Three Phase III studies; two with IL-17A IL-17F IL-25 H2H superiority study design vs. Stelara (ustekinumab) and placebo • First and second Phase III studies achieved primary and secondary en
Slide 16: Brodalumab (psoriasis): Positive Phase III data
Brodalumab (psoriasis): Positive Phase III data AMAGINE-1TM Phase III psoriasis data AMAGINE-3TM Phase III H2H may offer new level of skin clearance ustekinumab comparator 90 Placebo (N=81) 83.3 90 85.1 80 Broda. 140mg PASI 75/90/100 at 12 weeks Percent (%) of subjects with Broda. 210mg 70.3 80 Perc
Slide 17: Lifecycle management of first & best-in-class medicines
Respiratory, Inflammation & Autoimmunity: Lifecycle management of first & best-in-class medicines Highlighted Phase III and Phase II molecules: benralizumab severe asthma COPD tralokinumab severe asthma IPF atopic derm brodalumab* psoriasis psoriatic arthritis asthma sifalimumab/ SLE lupus nephritis
Slide 18: 2015: Duaklir launch, potential approval, submissions and Phase III starts
2015: Duaklir launch, potential approval, submissions and Phase III starts Duaklir Launch of LAMA-LABA in Genuair device in EU lesinurad Potential approval of first new MOA for gout in combination with XO brodalumab* Submission of IL17R for psoriasis PT003 Submission of first pMDI LAMA-LABA Phase II
Slide 19: Summary
Summary Strong respiratory portfolio broadened through Pearl and Almirall Positive data for first and best-in-class molecules in portfolio Most comprehensive portfolio of personalised precision therapies 19 – Pipeline: Respiratory, Inflammation & Autoimmunity (RIA)
Slide 20: Pipeline: Respiratory, Inflammation & Autoimmunity (RIA)
Pipeline: Respiratory, Inflammation & Autoimmunity (RIA) Inhaled therapeutic leadership; spearheading immunology biologics Bing Yao, Head of MedImmune Respiratory, Inflammation & Autoimmunity iMED